Job Title: Senior Clinical Trial Manager

Job Description

The Senior Clinical Trial Manager oversees the strategic operational management of pre- and post-market clinical studies. The role involves improving efficient execution of review and approval processes, contracting, and correspondence with study sites. You will be responsible for developing supporting clinical documents, coordinating site initiation, tracking enrollments, facilitating analyses, and reporting results. You will collaborate closely with Clinical Data Management, Biostatistics, Monitoring, and Regulatory Affairs departments to meet the goals and objectives of the clinical operations program. This includes ensuring study completion, data cleaning, analysis, regulatory submissions, and timely publication of study results. The role requires compliance with Clinical SOPs and GCP/ICH guidelines and supporting the development and periodic revision of Clinical SOPs. You will manage the development and review of study-specific documents and materials such as training presentations, project plans, monitoring plans, study logs, and newsletters. Ensuring operational and regulatory integrity of studies and participating in FDA or other regulatory authority inspections is crucial. You will also ensure that internal project team members are appropriately trained on proper study conduct and business processes. Additional responsibilities include managing relationships with consultants, contributing to budget management, and participating in clinical study site and vendor selection processes. You will support the recruitment, training, and management of Clinical Affairs staff, including Clinical Study Managers, Clinical Research Associates, and Clinical Coordinators.

Hard Skills

• Clinical SOPs compliance
• GCP/ICH guidelines
• Study protocols development
• Data cleaning and analysis
• Regulatory submissions
• Clinical study reports
• FDA inspections

Soft Skills

• Collaboration
• Team leadership
• Training and development
• Project management
• Communication
• Problem-solving

*Please send your resume and 2-3 professional references to hjaquez@ actalentservices.com for more information.*